Status:
COMPLETED
Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
Lead Sponsor:
Eidos Therapeutics, a BridgeBio company
Conditions:
Amyloidosis
Amyloid Cardiomyopathy
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Phase 3 efficacy and safety study to evaluate acoramidis (AG10) HCl 800 mg administered orally twice a day compared to placebo in subjects with symptomatic Transthyretin Amyloid Cardiomyopathy (ATTR-C...
Detailed Description
Transthyretin amyloid cardiomyopathy (ATTR-CM) is an underdiagnosed condition believed to affect more than 400,000 people worldwide. In ATTR-CM, the accumulation of transthyretin (TTR) amyloid results...
Eligibility Criteria
Inclusion
- Have an established diagnosis of ATTR-CM with either wild-type TTR or variant TTR genotype
- Have a history of heart failure evidenced by at least one prior hospitalization for heart failure or clinical evidence of heart failure without prior heart failure hospitalization manifested by signs or symptoms of volume overload or elevated intracardiac pressures or heart failure symptoms that required or require ongoing treatment with a diuretic.
- New York Heart Association (NYHA) Class I-III symptoms due to ATTR cardiomyopathy.
- On stable doses of cardiovascular medical therapy
- Completed ≥150 m on the 6MWT on 2 tests that are within 15% of total distance walked prior to randomization
- Biomarkers of myocardial wall stress, NT-proBNP level ≥300 pg/mL at screening
- Have left ventricular wall (interventricular septum or left ventricular posterior wall) thickness ≥12 mm
Exclusion
- Had acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening
- Has hemodynamic instability
- Likely to undergo heart transplantation within a year of screening
- Confirmed diagnosis of primary (light chain) amyloidosis
- Biomarkers of myocardial wall stress, NT-proBNP level ≥8500 pg/mL at screening
- Measure of kidney function, eGFR by MDRD formula \<15 mL/min/1.73 m2
- Current treatment with marketed drug products and other investigational agents for the treatment of ATTR-CM
- Current treatment with calcium channel blockers with conduction system effects (e.g. verapamil, diltiazem). The use of dihydropyridine calcium channel blockers is allowed. The use of digitalis will only be allowed if required for management of atrial fibrillation with rapid ventricular response
Key Trial Info
Start Date :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT03860935
Start Date
March 19 2019
End Date
May 11 2023
Last Update
June 27 2024
Active Locations (104)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Pacific Heart Institute
Santa Monica, California, United States, 90404
3
University of Colorado Hospital - Anschutz Medical Campus
Aurora, Colorado, United States, 80045
4
Yale School of Medicine
New Haven, Connecticut, United States, 06473